2022
DOI: 10.1007/s40264-022-01254-4
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Development and Evaluation of the Algorithm CErtaInty Tool (ACE-IT) to Assess Electronic Medical Record and Claims-based Algorithms’ Fit for Purpose for Safety Outcomes

Abstract: Introduction Electronic health record (EHR) or medical claims-based algorithms (i.e., operational definitions) can be used to define safety outcomes using real-world data. However, existing tools do not allow researchers and decision-makers to adequately appraise whether a particular algorithm is fit for purpose (FFP) to support regulatory decisions on drug safety surveillance. Our objective was to develop a tool to enable regulatory decision-makers and other stakeholders to appraise whether a given algorithm … Show more

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“…The fit for purpose of any RWE algorithm is dependent on its context of use 1 and both internal validity (eg, algorithm performance within this study) and external validity (eg, generalizability of the algorithm to the real-world data source where it will be applied for conducting future research) should be assessed by researchers considering whether to use the algorithm. 26 In our view, based on the performance of the final point-score in terms of its sensitivity and PPV, the final point-score NSCLC algorithm is likely fit for purpose for general disease state studies including burden of illness and treatment patterns. Researchers should consider the algorithm’s performance in the context of their study question and data source, as described in the Certainty Framework for real-world data variables.…”
Section: Discussionmentioning
confidence: 99%
“…The fit for purpose of any RWE algorithm is dependent on its context of use 1 and both internal validity (eg, algorithm performance within this study) and external validity (eg, generalizability of the algorithm to the real-world data source where it will be applied for conducting future research) should be assessed by researchers considering whether to use the algorithm. 26 In our view, based on the performance of the final point-score in terms of its sensitivity and PPV, the final point-score NSCLC algorithm is likely fit for purpose for general disease state studies including burden of illness and treatment patterns. Researchers should consider the algorithm’s performance in the context of their study question and data source, as described in the Certainty Framework for real-world data variables.…”
Section: Discussionmentioning
confidence: 99%